FDA Announces Final Guidance on Drug Pharmacy Compounding

Product Id : FDA56
Instructor : Rachelle D'Souza
Nov 03, 2017 1:00 PM ET | 12:00 PM CT | 10:00 AM PT | 60 Minutes

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The new rules for compounding pharmacies creates clearer definitions of the drugs that can be compounded, the ingredients that can be used or must be avoided, the facilities and personnel that be involved in compounding of drugs, labeling and shipping requirements, and documentation that must be created and maintained to demonstrate compliance.

This webinar will discuss conditions under which certain compounded human drug products are exempted from compliance with cGMPs, labeling, market approval and reporting requirements. It will cover conditions that require an outsourcing facility to comply and the latest developments in drug pharmacy compounding.

Why Should You Attend:

Do you know of sections 503A and 503B of the Federal Food, Drug and Cosmetic Act (FDCA) as it relates to drug compounding?

Section 503A provides conditions under which certain compounded human drug products are exempted from requirements such as compliance with current good manufacturing practices (CGMPs), labeling with adequate directions for use and FDA market approval. New section 503B of the FDCA enables a compounder to register with FDA to become an “outsourcing facility.” Outsourcing facilities are exempt from the above label compliance and FDA market approval requirements but are still subject to CGMP compliance, risk based FDA inspections and certain reporting requirements such as adverse event reporting.

In the 503A Guidance,FDA has removed everything IACP had requested from Category 3 of the Bulks list – including: capsules, lecithin soya granular, loxasperse, MBK, medium cream, pracasil, shea butter, simplgel, supposibase-F, tommygel, some cosmetic ingredients, L-triiodothyronine, T3 sodium dilution, quinine, splenda, buffer solution, minerals, triglycerides and water (and additives).

This training seeks to inform hospital or stand-alone pharmacies, pharmacy state boards, pharmacists, health care professionals, hospitals on the various FDA documents including the latest developments concerning this topic.

Learning Objectives:

  • To practice pharmacy drug compounding under a state of quality compliance and without violation of the law.
  • Understand the rights of the compounding pharmacy in accordance with FDA requirements
  • Explain the rights of manufacturers and drug patent regulations
  • Understand the role of state pharmacy boards
  • Determine next steps for compounding pharmacies to ensure compliance
  • Sections 503A and 503B, FDCA & various FDA documentation
  • Outsourcing facility registration and reporting

Who will Benefit:

  • Hospitals or stand-alone pharmacies
  • Pharmacy state boards
  • Health care professionals
  • Compliance officers
  • Documentation specialists
Speaker Profile:

Rachelle D’Souza, CEO of Regulatory Heights Inc., has successfully licensed various medical and consumer products and facilities with international regulatory authorities / agencies for multinational and start-up companies. Her expertise also includes clinical trial master file documentation, and the design and maintenance of globally compliant quality, safety / pharmacovigilance and medical information systems.

At Regulatory Heights Inc., Rachelle continuously monitors the current regulatory environment and utilizes regulatory intelligence as a strategic business driver for her clientele. Her numerous articles on the latest international regulatory developments have been published in print and on-line by regulatory professional associations and industry magazines around the world.

Her versatility has enabled Regulatory Heights Inc. to support companies, in particular, start-ups with the licensing of their drugs and medical devices in international markets.

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